Cleared Traditional

K170754 - 3M Tegaderm Antimicrobial Transparent D...

K170754 · 3M Company, 3M Healthcare · General & Plastic Surgery device
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Nov 2017
Decision
253d
Days
-
Risk

K170754 is an FDA 510(k) clearance for the 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company, 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 253 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Company, 3M Healthcare devices

FDA 510(k) Submission Details - K170754

510(k) Number K170754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date November 21, 2017
Days to Decision 253 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 115d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 237
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K170754.
Algidex Ag Silver Alginate Wound Dressing
K173072 · Deroyal Industries, Inc. · Apr 2018
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016